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AI-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

This study is looking at how well artificial intelligence (AI) can help find a heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM) in adults who have heart failure. Researchers are using AI models with your electrocardiogram (ECG) and echocardiogram (Echo) results. The goal is to see if these AI models can accurately identify ATTR-CM, which will be checked against a special heart scan called a technetium-99m pyrophosphate (PYP) scan. You might be able to join if you are 18 or older, have heart failure (specifically HFpEF or HFmrEF), and have had both an ECG and Echo at YNHHS. The study plans to include about 150 participants.

Study design
This is an observational study, meaning researchers will be watching and collecting information without giving you a specific treatment. It aims to enroll about 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for the study will be taken from enrollment through the completion of your PYP scan at your baseline study visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07398950

Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Enrolling by Invitation
Not specifiedAges 18+Observational
Yale University
~150 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:ATTR-CM AI-ECG and AI-Echo Model

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance of the sequential screening approach
Measured over From enrollment through completion of PYP scan at baseline study visit

Conditions

ATTR Amyloidosis With Cardiomyopathy
Heart Failure

Explore related trials

Heart FailureTransthyretin related familial amyloid cardiomyopathy

NCT07398950

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale New Haven Health System

    New Haven, Connecticutno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rohan Khera, MD, MS · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Patients 18 years or older with at least one of each component cardiovascular diagnosis testing (ECG and Echo) in the YNHHS.
Patients with a diagnosis of HFpEF or HFmrEF
Participant from Phase I TRACE-AI Study with AI-ECG and AI-Echo screen in the preceding 36 months

Exclusion

Patients who have opted out of research studies
Patients with cardiac amyloid diagnostic test in the past 36 months
Patients with hypertrophic cardiomyopathy or end-stage renal disease
Pregnant women
Patients unable or unwilling to provide informed consent
Non-English speakers and cognitively impaired individuals who are unable to comprehend the consent and the on-screen instructions on the application, which are in English.

What this trial measures

  • Performance of the sequential screening approachFrom enrollment through completion of PYP scan at baseline study visit

    Measured by the positive predictive value (PPV) of the test for ATTR-CM, based on confirmatory imaging and clinical testing